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CinnaTropin® (Somatropin, HGH, Human Growth Hormone)

10 mg/1.5 ml

• 30 IU (equivalent to 10 milligrams)

• 1 Sterile pre-filled pen (1.5 ml)

• For subcutaneous injection only

1. What CinnaTropin® is and what it is used for

CinnaTropin® contains a biosynthetic human growth hormone called somatropin. It is used to treat growth failure in children:

• If they have no or very low production of growth hormone (growth hormone deficiency)

• If they have Turner syndrome (a genetic problem which may affect growth)

• If they are short and were born small for gestational age (SGA)

• If they have Noonan syndrome (a genetic problem which may affect growth)

CinnaTropin® is also used to replace growth hormone in adults:

• In adults, CinnaTropin® is used to replace growth hormone if their production has decreased since childhood or been lost due to a tumor, treatment of a tumor, or a disease that affects the gland that produces growth hormone. If growth hormone deficiency is confirmed, you should continue treatment.

2. What you need to know before you use CinnaTropin®

Do not use CinnaTropin® if:

• You are allergic to somatropin, phenol, or any other ingredients in this medicine

• You have cancer or are undergoing treatment for cancer

• You have had a kidney transplant

• You have stopped growing (closed epiphyses)

Warnings and precautions:

• If you have diabetes

• If you have ever had cancer or another kind of tumor

• If you have headaches, eyesight problems, or nausea/vomiting

• If you are treated with glucocorticoids, thyroid hormone, or other medications that may interact with growth hormone.

3. How to use CinnaTropin®

Always use this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

Paediatric population:

• Growth hormone insufficiency: 0.025-0.035 mg/kg/day

• Turner syndrome: 0.045-0.067 mg/kg/day or 1.3-2.0 mg/m²/day

• Chronic renal disease: 0.050 mg/kg/day or 1.4 mg/m²/day

• Noonan syndrome: 0.066 mg/kg/day

In adults:

• The dose varies based on the individual’s needs and is usually 0.15-0.30 mg/day, but it can go up to 1.0 mg/day depending on the person’s response to treatment.

If you forget to take CinnaTropin®, use the missed dose as soon as possible but do not double the dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this drug may cause side effects, though not everyone experiences them.

Very common (may affect more than 1 in 10 adults):

• Swollen hands and feet due to fluid retention

Common (may affect up to 1 in 10 adults):

• Headache

• Joint pain, stiffness, muscle pain

• Tingling and pain in fingers and hands

• Skin reactions at the injection site

Uncommon (may affect up to 1 in 100 adults):

• Type 2 diabetes

• Carpal tunnel syndrome

• Breast enlargement (gynaecomastia)

In children:

• Redness, itching, and pain at the injection site

• Breast enlargement (gynaecomastia)

• Rash

5. How to store CinnaTropin®

• Keep out of the sight and reach of children.

• Store the CinnaTropin® pen at 2-8°C before first use. After the first use, it can be stored at room temperature (up to 25°C) for three weeks or in the refrigerator (2-8°C) for four weeks.

• Do not freeze.

• Keep the pen in its original packaging to protect from light.

• Do not use the product after the expiration date on the carton and label.

• Do not use a pack that is damaged or shows signs of tampering.

• Dispose of the medication according to local guidelines to protect the environment.

6. Contents of the pack and other information

What CinnaTropin® contains:

• The active substance is somatropin

• The other ingredients are mannitol, histidine, poloxamer 188, phenol, and water for injection.

What CinnaTropin® looks like and contents of the pack:

• CinnaTropin® is a clear, colorless solution in a 1.5 ml glass cartridge ready for injection.

• Each pack contains one prefilled pen and a patient information leaflet.